Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

Bayer

Status and phase: Completed; Phase 1

Conditions: Anti-Infective Agents

Treatments: Drug: Cephalexin suspension (Optocef, BAYO5448 ); Drug: Cephalexin suspension (Keflex)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105208

15188

Biocef-S (Other Identifier)

Details and patient eligibility

About

A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion criteria

• History of illnesses or any organic abnormalities that could affect the results of the study
• History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs
• Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Cephalexin suspension (Optocef, BAYO5448 )

Arm 2

Active Comparator group

Treatment:

Drug: Cephalexin suspension (Keflex)